Design Quality Engineer (medical devices)

We are Looking an experienced Senior Design Quality Project Manager to lead global product transfer and design quality initiatives for complex medical devices and combination products. This role will serve as the quality lead for cross-functional product transfer projects, partnering with Design Engineering, Manufacturing Engineering, Operations, Regulatory Affairs, Supply Chain, and Quality teams to successfully transfer products between global manufacturing sites while ensuring compliance with FDA and international regulatory requirements., * Lead global product transfer projects for Class II and Class III medical devices and combination products from planning through commercial manufacturing.

• Serve as the Design Quality representative for new product introductions (NPI), design transfers, manufacturing site transfers, and product lifecycle management initiatives.
• Develop and manage project plans, timelines, budgets, risks, and deliverables while ensuring projects remain on schedule.
• Partner with Design Engineering, Manufacturing Engineering, Operations, Supply Chain, Regulatory Affairs, Validation, and Quality teams to execute successful product transfers.
• Provide hands-on quality engineering support throughout project execution, including design reviews, technical assessments, investigations, and risk management activities.
• Support establishment of new manufacturing lines, equipment qualification, process validation, and manufacturing readiness activities.
• Ensure compliance with FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, EU MDR, and other applicable regulatory requirements.
• Lead Design Transfer activities, ensuring Design History File (DHF), Device Master Record (DMR), and manufacturing documentation are complete and compliant.
• Drive Design Change, Engineering Change Orders (ECOs), Change Control, CAPA, and Nonconformance activities associated with transferred products.
• Facilitate Design Reviews, Risk Reviews, Transfer Readiness Reviews, and cross-functional governance meetings.
• Apply risk management principles in accordance with ISO 14971 to identify, assess, and mitigate product and process risks.
• Coordinate verification, validation, process validation (IQ/OQ/PQ), manufacturing validation, and inspection readiness activities.
• Identify quality, technical, manufacturing, and supply chain risks early and develop mitigation plans.
• Present project status, quality metrics, transfer readiness, and executive updates to senior leadership.
• Mentor project teams and provide technical leadership on Design Quality best practices.

This position is ideal for someone who combines strong project management skills with hands-on Design Quality Engineering experience and has successfully led manufacturing transfers, design transfer activities, and new production line implementations within the medical device industry., * Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, Manufacturing, Industrial, or related discipline). Master’s degree preferred.

• Certified Project Manager (PMP or equivalent) strongly preferred.
• 8+ years of experience in Design Quality Engineering, Quality Engineering, Product Development, or Manufacturing Quality within the medical device industry.
• 5+ years leading cross-functional global product transfer or design transfer projects.
• Demonstrated experience leading global manufacturing transfers for medical devices or combination products.
• Hands-on experience supporting Design Quality activities-not solely project coordination.
• Experience working directly with manufacturing and engineering teams to establish new production lines and manufacturing operations.
• Strong understanding of Design Controls (21 CFR Part 820.30), Design Transfer, and Product Lifecycle Management.
• Experience with:
• Design History File (DHF)
• Device Master Record (DMR)
• Device History Record (DHR)
• Engineering Change Orders (ECO)
• Change Control
• CAPA
• Nonconformance Management
• Root Cause Analysis
• Working knowledge of:
• FDA 21 CFR Part 820 / QMSR
• ISO 13485
• ISO 14971
• EU MDR
• IEC 62304 (preferred)
• IEC 60601 (preferred)
• Experience supporting Verification & Validation (V&V), Process Validation (IQ/OQ/PQ), equipment qualification, and manufacturing readiness.
• Strong project management skills with experience managing project schedules, risks, budgets, and stakeholder communications.
• Excellent presentation, communication, facilitation, and leadership skills.
• Ability to influence cross-functional teams across multiple global sites.

Preferred Qualifications

• Master’s degree in Engineering or related technical discipline.
• PMP (Project Management Professional), Certified Project Manager (CPM), CQE, or ASQ certifications.
• Experience with combination products and drug-device products.
• Experience supporting New Product Introduction (NPI) and commercial launch activities.
• Knowledge of supplier quality, manufacturing process development, and technology transfer.
• Experience with PLM systems (Windchill, Agile, Teamcenter), eQMS (Veeva, MasterControl, TrackWise, ETQ), and ERP systems (SAP, Oracle).
• Experience working with contract manufacturers (CMOs/CDMOs) and global manufacturing sites.
• Familiarity with statistical analysis, process capability, Lean Six Sigma, and continuous improvement methodologies.

Pay: $40.00 - $70.00 per hour